We have exhibited our devices on the prestigious MEDTEC UK exhibition in Birmingham

ONKOCET Ltd. has exhibited the devices from its portfolio on the MEDTEC UK exhibition in Birmingham, April 2011 through our partner Medical & Partners.

12.4.2011 12:27

Certification of SVIT infrared camera completed

The ONKOCET company has successfully reached the certification of yet another medical device, Infrared Camera SVIT. The Certificate can be found here. The videos from the device operation can be found here.

In October 2009 we have received CE certificate for another device from our portfolio, NO therapeutical device PLASON. You can find more information about this revolutionary device, used for healing of unhealing wounds, diabetic foot, or for cosmetical purposes, at our webpage, section "Medical devices" -> PLASON-NO Therapy.

Best regards

Team of ONKOCET Ltd. company

23.1.2009 15:30

Accuracy and reliability

RELIABILITY, ACCURACY AND SAFETY OF MEDICAL DEVICES

In the beginning of 2013 on the site of ResearchGate https://www.researchgate.net/ Phil Petursson raised a question: How do you know that medical devices are reliable, accurate, and safe?

Petursson wrote: “I believe that approval ratings that include: 'CE', 'UL', and 'GS' are only electrical safety ratings, and do not evaluate the reliability and validity (accuracy) of a medical device.“

Is it true that the CE mark on medical devices (MD) means only electrical safety ratings?

Before any producer of medical device labels his product with the CE mark and introduces them on EU market with medical devices, the device must fulfill the conditions written in Directive 93/42/EEC (MDD), 98/79/EC (IVDD) or 90/385/EEC (AIMDD). In practice this process is called „CE registration“.

What does the process of CE registration mean?

The process of CE registration is divided into two parts. First, each producer or EU representant of a manufacturer is obliged to prepare a so called Technical Construction File (TCF).